A randomised, double blinded, placebo controlled trial of the effect of self administered methoxyflurane using the Penthrox® Inhaler on tolerance of the Computed Tomography (CT) Enteroclysis procedure

Completed

• Conditions: CT enteroclysis tolerance; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12608000058370
• Lead Sponsor: Dr Alan Moss, Principal Investigator, Penthrox for CTE trial

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Referred for CT enteroclysis
Age 16 years or older
Able to give written informed consent themselves

Exclusion Criteria

Known pre-existing renal or hepatic impairment: serum creatinine = 1.5 x upper limit of normal range (ULNR) or bilirubin = 2 x upper limit of normal range (ULNR).
Concomitant use of any of the following medications: tetracyclines, gentamicin, kanamycin, colistin, polymyxin b, cephaloridine or amphotericin b.
Personal or familial hypersensitivity to fluorinated anaesthetics.
Personal or familial malignant hyperthermia.
Pre-medication with anxiolytic eg. midazolam, diazepam.
Pre-medication with breakthrough dose of analgesic eg. paracetamol plus codeine or oxycodone.
Hypotension pre-procedure: systolic blood pressure <90 mmHg.
Bradycardia pre-procedure: heart rate <50 bpm.
Poor oxygen saturation pre-procedure: O2 saturation <90%.
Pregnancy: currently pregnant or attempting to become pregnant.
Lactation: currently breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified